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Tysabri
natalizumab
Black Box Warnings .
Appropriate Use
restricted distribution program (TOUCH REMS) due to PML risk; prescribers, pharmacies, infusion centers, and pts must enroll at 1-800-456-2255
Progressive Multifocal Leukoencephalopathy
incr. PML risk; risk factors for PML incl. presence of anti-JCV antibodies, longer tx duration, and prior immunosuppressant use; consider risk factors in context of expected benefit when starting or continuing tx; monitor for PML s/sx and D/C tx immediately if suspected; diagnose via gadolinium-enhanced brain MRI and when indicated, CSF analysis for JC viral DNA
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-800-456-2255 or www.tysabri.com for more info]
multiple sclerosis, relapsing forms
- [300 mg IV q4wk]
- Info: for monotherapy in pts w/ clinically isolated syndrome, relapsing-remitting dz, or active secondary progressive dz
Crohn dz, moderate-severe
- [300 mg IV q4wk]
- Info: for pts w/ inadequate response or intolerance to other tx; D/C after 12wk if no benefit; if on chronic steroids, start tapering as soon as natalizumab benefit seen; D/C natalizumab if initial steroid taper not complete w/in 6mo of natalizumab start; consider D/C natalizumab if later steroid use >3mo/yr
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.